Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (loss of sterility) in a medical device used for invasive procedures, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 717 boxes of CIVCO Infiniti Plus Needle Guides, Sterile Needle Guide, 12-18GA. The product is used in needle-guided or catheter procedures with diagnostic ultrasound transducers. The recall is being conducted because the sterility of the product cannot be assured.
The affected products are identified by reference numbers 610-1215, 610-1234, 610-1235, and 610-1236. The recall covers a worldwide distribution, including the United States (nationwide) and international locations such as Australia, Canada, China, Germany, Japan, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected needle guides. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device — Needle Guide
- Hazard
- Affected units
- 717
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- M367350
- M370110
- M375100
- M381740
- M406940
- M407750
- M413300
- M413310
- M434210
- M436400
- M445180
- M647110
- M093610
- M113720
- M122370
- M153900
- M206940
- M250330
- M250340
- M258890
Distribution
Part of a larger recall action
This product is one of 5 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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